Cyclic Breast Pain, Cyclic MastalgiaPhase 2NCT00272714
Study of Afimoxifene Gel to Treat Cyclic Mastalgia in Premenopausal Women
A Phase 2 study testing Afimoxifene (0.057%) in hydroalcoholic gel in people with Cyclic Breast Pain, Cyclic Mastalgia, run by ASCEND Therapeutics.
Trial summary
The purpose of this study is to evaluate the efficacy of two doses of 4-hydroxy tamoxifen (4-OHT) compared with placebo on the intensity of cyclic mastalgia in pre-menopausal women with regular menstrual cycles who are not taking oral contraceptives. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cyclic Breast Pain, Cyclic Mastalgia
- What is being tested?
- Afimoxifene (0.057%) in hydroalcoholic gel
- How many people
- 146 participants
- Where
- No sites listed yet
- Study dates
- Mar 2003to Apr 2005
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A woman is eligible for this study if she:
- is pre-menopausal and at least 18 years of age.
- has a history of cyclical mastalgia for each of the four months prior to study entry.
- moderate or severe mastalgia as determined by >40 mm on the VAS for ≥7 days per cycle in the second part of the cycle, i.e. 13 days prior to menses and the first two days of the next cycle with a substantial decrease during the two weeks following the onset of menses, assessed during the two month run-in period.
- has a history of regular menstrual cycles of 28 plus/minus 3 days.
Who cannot join
- -
About this study
Official title: A Phase II, Randomized, Double-Blind, Two-Dose, Placebo-Controlled Multicentre Study of 4-Hydroxy Tamoxifen Gel for Cyclical Mastalgia in Otherwise Healthy Pre-Menopausal Women With Regular Menstrual Cycles.
The purpose of this study is to evaluate the efficacy of two doses of 4-hydroxy tamoxifen (4-OHT) compared with placebo on the intensity of cyclic mastalgia in pre-menopausal women with regular menstrual cycles who are not taking oral contraceptives.
Read the detailed description
This study is a Phase II, randomised, double-blind, placebo-controlled, two-dose, multicentre trial of 4-OHT gel in approximately 130 otherwise healthy pre-menopausal women with a history of cyclical mastalgia, peaking during the second half of the menstrual cycle and decreasing significantly with the onset of menstruation, during the four months prior to study entry.
The primary efficacy endpoint in this study is change in change in average pain Visual Analog Scale (VAS) scores for the seven worst pain scores within a cycle, from baseline to the fourth cycle after start of treatment.
- Conditions
- Cyclic Breast Pain, Cyclic Mastalgia
- Being tested
- Afimoxifene (0.057%) in hydroalcoholic gel
- Keywords
- breast pain, tenderness, benign breast conditions
- Medical subject headings
- Mastodynia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Afimoxifene (0.057%) in hydroalcoholic gelDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Visual Analog Scale (VAS) scores for the seven worst scores within a cycle, from baseline to the forth cycle after treatment
Secondary outcomes (7)
Change from baseline in average VAS pain scores for the seven worst pain scores within a cycle over all cycles
Change from baseline in average VAS pain scores over all scores over all cycles
Change from baseline in the number of nominal days of breast pain (NDBP) over all cycles using the Cardiff Breast Pain Chart.
Physician's global assessment of pain.
Physician's clinical evaluation of mastalgia (tenderness determined by palpation).
Physician's clinical evaluation of mastalgia (nodularity).
Patient's global assessment of pain.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2006 (estimated)
- Study startMar 2003
- Primary completionMar 2004
- Study completionApr 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cyclic Breast Pain, Cyclic MastalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- ASCEND Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert E Mansel, MD, Principal investigator, University of Wales College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00272714
- Sponsor's protocol ID
- 01-4OHT-02
- Status last verified
- Jul 2013
- First submitted
- 5 Jan 2006
- Last updated
- 16 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomized, Double-Blind, Two-Dose, Placebo-Controlled Multicentre Study of 4-Hydroxy Tamoxifen Gel for Cyclical Mastalgia in Otherwise Healthy Pre-Menopausal Women With Regular Menstrual Cycles.
- ClinicalTrials.gov ID
- NCT00272714
- Acronym / sponsor ID
- 01-4OHT-02
- Conditions
- Cyclic Breast Pain, Cyclic Mastalgia
- Keywords
- breast pain, tenderness, benign breast conditions
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- ASCEND TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Mar 2003
- Primary completion
- Mar 2004 (actual)
- Study completion
- Apr 2005 (actual)
- First posted
- 9 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy of two doses of 4-hydroxy tamoxifen (4-OHT) compared with placebo on the intensity of cyclic mastalgia in pre-menopausal women with regular menstrual cycles who are not taking oral contraceptives.
Detailed description
This study is a Phase II, randomised, double-blind, placebo-controlled, two-dose, multicentre trial of 4-OHT gel in approximately 130 otherwise healthy pre-menopausal women with a history of cyclical mastalgia, peaking during the second half of the menstrual cycle and decreasing significantly with the onset of menstruation, during the four months prior to study entry.
The primary efficacy endpoint in this study is change in change in average pain Visual Analog Scale (VAS) scores for the seven worst pain scores within a cycle, from baseline to the fourth cycle after start of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- A woman is eligible for this study if she:
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Afimoxifene (0.057%) in hydroalcoholic gel | Drug | – |
Primary outcome
Change in Visual Analog Scale (VAS) scores for the seven worst scores within a cycle, from baseline to the forth cycle after treatment
7 secondary outcomes
Change from baseline in average VAS pain scores for the seven worst pain scores within a cycle over all cycles
Change from baseline in average VAS pain scores over all scores over all cycles
Change from baseline in the number of nominal days of breast pain (NDBP) over all cycles using the Cardiff Breast Pain Chart.
Physician's global assessment of pain.
Physician's clinical evaluation of mastalgia (tenderness determined by palpation).
Physician's clinical evaluation of mastalgia (nodularity).
Patient's global assessment of pain.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2023.
Related trials for Cyclic Breast Pain, Cyclic Mastalgia
Not yet recruiting
Study on the Effects of Acupuncture in Patients with Cyclic Mastalgia
Breast Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert E Mansel, MD principal investigator
University of Wales College of Medicine
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Afimoxifene (0.057%) in hydroalcoholic gel in people with Cyclic Breast Pain, Cyclic Mastalgia, run by ASCEND Therapeutics.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Visual Analog Scale (VAS) scores for the seven worst scores within a cycle, from baseline to the forth cycle after treatment. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2023.